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- 2026-05-09 07:24:00
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- Daewoong recovers with record 2Q sales of ₩289.7 billi
- by An, Kyung-Jin Jul 30, 2021 05:48am
- Daewoong has continued its good performance for 2 consecutive quarters. By overcoming the heavy blows it took from the impurity issue in ranitidine and the lawsuits from its botulinum toxin strain dispute, the company was able to raise its quarterly sales to the highest level despite the COVID-19 crisis. Daewoong Pharmaceuticals has posted its operating profit of ₩26.7 billion in Q2 this year and marked a turnaround compared to the same quarter of the previous year. The company turned into a profit this quarter with its sales revenue increasing 20.8% to ₩273.1 billion and a net income of ₩14.5 billion. Its cumulative sales revenue in the first half of this year was ₩514.7 billion, a 13.3% year-on-year increase. Daewoong Pharmaceuticals had suffered from a poor performance last year. The detection of impurities in the heartburn treatment ingredient ranitidine led to a large sales gap in its key product ‘Albis.’ Also, the company had spent much expense in lawsuit over the botulinum toxin strain dispute with Medytox. In this year, the company has seen an improvement in its profitability with the revenue accrued from ‘Fexuprazan,’ which the company is developing as a treatment of gastroesophageal reflux, and the risk from ‘Nabota’ lawsuits being resolved. Also, the increase in sales became greater due to strong performance in the domestic market and in exports. Sales of the botulinum toxin product ‘Nabota’ has more than quadrupled in Q2 to record ₩23.2 billion, compared to the ₩5.6 billion in Q2 last year. With the risk from suits in the U.S. fully resolved, its U.S. market share has started to expand in earnest, and Daewoong Pharmaceuticals is also stepping up its efforts to expand to new markets overseas for ‘Nabota,’ including in Latin America and the Middle East. Sales in the prescription drugs sector recorded ₩196.1 billion, an 8.7% increase compared to the ₩179.4 billion in the same period of the previous year. Sales of Daewoong’s self-developed drugs including the liver drug ‘Ursa (ETC),’ anticancer drug ‘Luphere Depot,’ and combination hyperlipidemia drug ‘Crezet,’ as well as the drugs it introduced to Korea such as the anti-diabetic ‘Forxiga,’ anti-coagulant ‘Lixiana,’ and its 3-drug combination for hypertension ‘Sevikar’ had all increased evenly. In the OTC sector, the company recorded average sales - from ₩29.6 billion in the same period last year to ₩28.6 billion this year. Its high-dose vitamin B complex, ‘Impactamin,' and the liver function enhancer ‘Ursa(OTC)’ have maintained stable sales. Also, the technological fee from R&D projects has become a new source of revenue for the company. In Q2, the company made ₩11.1 billion from a U.S. licensing-out contract for ‘Fexuprazan,’ a new drug for gastrointestinal reflux.
- Company
- SK Group's Pharma companies make successive success
- by Lee, Seok-Jun Jul 30, 2021 05:48am
- SK Group’s pharmaceutical companies have successively succeeded in raising large-scale funds. The analysis is that being able to invest in independent corporations differentiated by business characteristics attracted market investment. SK Group’s pharmaceutical companies, which all use the SK name, are operated in different areas by SK or SK Discovery without mixed shares. SK operates SK Biopharmaceuticals (new drug development) and SK Pharmteco (CMO). SK Discovery operates SK Chemical (pharmaceutical business), SK Plasma (blood products), and SK Bioscience (vaccines). SK Plasma, a non-listed company, recently raised ₩110 billion through a third-party allocation paid-in capital increase. SK Plasma receives ₩40 billion from SK Discovery and ₩30 billion each from Tiumbio and Korea Investment Partners as an investment. SK Plasma was established in March 2015 as a spin-off from SK Chemicals. It manufactures and sells various plasma-derived products including the Human Normal Immunoglobulin Liv-Gamma SN Inj., Human Plasma-derived Hepatitis B Immunoglobulin Hepabulin SN Inj., Human Albumin Solution Albumin inj., SK Antithrombin III Inj., Tetabulin SN Inj., etc. COVID-19 vaccine developer SK Bioscience raises ₩1.4918 trillion at IPO SK Bioscience and SK Biopharmaceuticals raised large-scale funds through IPOs. SK Bioscience, which made its debut on KOSPI on March 18th, raised ₩1.4918 trillion at an offering price of ₩65,000 a share. SK Bioscience is a company specializing in vaccines that was spun off from SK chemicals in July 2018. It carries out the total process from R&D in the vaccine sector, production, sales to distribution. SK Bioscience was the first Korean company to apply for a Phase III trial for a COVID-19 vaccine candidate (GBP510) on the 28th of last month. The company is also developing another COVID-19 vaccine candidate (NBP2001). SK Biopharmaceuticals, which has two US-approved new drugs, raise ₩959.3 billion SK Biopharmaceuticals also raised ₩959.3 billion in funds at an IPO price of ₩49,000 on July 2nd of last year. SK Biopharmaceuticals is a new company that is in charge of new drug development and sales that was founded after a spilt-off of SK’s life science business in 2011. 2 new drugs that have been developed by SK Biopharmaceuticals are currently released globally. 'Sunosi,' a treatment for sleepiness developed by SK Biopharmaceuticals in 2011 and licensed out to Jazz Pharmaceuticals, was approved in the U.S. in March 2019. Also, its independently developed epilepsy treatment ‘ExcoFree’ was approved in the U.S. in November 2019.
- Company
- Emgality and Ajovy were also approved
- by Kim, Jin-Gu Jul 30, 2021 05:47am
- Following Lilly's Emgality (Galcanezumab), Teva's Ajovy (Fremanezumab) were released in Korea as a new medicine for migraine prevention. Attention is focusing on whether CGRP (calcitonin gene-related peptide) drugs, which have entered the domestic migraine treatment market without suitable treatments, will become popular. Emgality, Ajovy, and Aimovig Aimovig is not yet authorized in Korea. On Wednesday, the MFDS approved Teva Handok's migraine prevention drug Ajovy. It is the second CGRP drug after Lilly's Emgality. Emgality was granted permission in September 2019. It was released in December of that year as non reimbursed drug. Amgen is reportedly aiming for another CGRP drug, Aimovig (Erenumab), to enter Korea. If Aimovig is released, competition for three drugs is expected to proceed as well as in the global market. The three drugs combine with CGPR, known as migraine-causing substances, to block the action of receptors. It is the first preventive treatment that targets migraines only. In the U.S., it was approved one after another from May to September 2018 in order of Aimovig, Ajovy, and Emgality. As of last year, global sales include Aimovig $378 million, Emgality $199 million, and Ajovi $165 million. There have been no suitable migraine treatments in the domestic market. Although both acute and preventive treatments were possible, existing treatments had clear limitations. General painkillers such as Acetaminophen and Ibuprofen, which are used to treat acute conditions, and triptans-based drugs have different effects, and they have caused drug-induced headaches when overused. The triptane series has also reported side effects of excessive blood vessels contracting. In the case of preventive treatment, beta blockers, CCB (calcium channel blockers), ABR (angiotensin receptor blockers), antidepressants, and epilepsy treatments, which are high blood pressure drugs, were partially. However, it was not widely used in that it was not developed for the purpose of treating migraines. Recently, Botulinum toxin injections have been actively attempted. However, it is only for chronic migraines, and it was burdensome for patients to get about 30 injections every three months. The market size of migraine drugs in Korea is not large. According to UBIST, prescription amount of triptans-related drugs in Korea was only ₩15.5 billion as of last year. If the remaining drugs are added to this, it will be around ₩30 billion per year. The new line of drugs is expected to increase sales in the migraine market. According to the Korea Headache Society, the prevalence of migraines in Korea is around 6%. In fact, 2.6 million people have migraines. However, the actual number of patients treated for migraines in hospitals was 550,000 (the HIRA's statistics) as of 2020. In other words, there are about 2 million potential patients. The key is whether or not the benefit will be applied. Emgality, which was first released in Korea, submitted an application for health insurance benefits in March. Currently, it is between ₩500,000 and ₩700,000 at a time as non-reimbursement in Korea. Ajovy from Teva Handok is also expected to apply for insurance benefits soon.
- Company
- Chong Kun Dang applied for Lucentis biosimilar
- by Chon, Seung-Hyun Jul 30, 2021 05:47am
- Chung Kun Dang announced on the 28th that it has applied to the MFDS for permission for the item of the macular denaturation drug CKD-701. CKD-701(Ranibizumab) is a biosimilar product from Lucentis. Lucentis, sold by Roche and Novartis, is a drug used to treat ophthalmic diseases such as macular degenerative diabetes and macular edema. Lucentis' annual global sales amounted to about ₩4.6 trillion. Chung Kun Dang confirmed clinical equivalence with Lucentis through phase 3 of CKD-701, which was conducted at 25 hospitals including Seoul National University from September 2018 to March this year for 312 patients with 312 patients with age-related macular degeneration. Chung Kun Dang administered CKD-701 and original drugs respectively to patients with wet macular degeneration and analyzed the maximum calibration vision (BCVA) after three months. The assessment found that the proportion of patients with vision loss of less than 15 characters was 97.95%, or 143 out of 146 in the CKD-701 administration group, and 98.62%, or 143 out of 145 in the original drug administration group, which met the equivalence range. The average change in maximum calibration vision also showed no statistical difference between the two drugs as the CKD-701 administration group improved to 7.14 words and the original drug to 6.28 words. There were no statistically significant differences in drug efficacy and other pharmacokinetics, immunogenicity and safety in indicators such as the proportion of patients with less than 15 letters of vision loss and better vision, average changes in maximum calibration vision, and changes in central retinal thickness, respectively. If CKD-701 is approved, Chong Kun Dang will produce a second biosimilar. Chung Kun Dang was approved by Nesp's biosimilar Nesbell in late 2018. "If CKD-701 is approved, we expect patients to have a variety of treatment options. Starting with the domestic market worth ₩37 billion, we will expand the market to Southeast Asia and the Middle East," said an official at Chong Kun Dang.
- Company
- Sales of Takeda’s drugs 'acquired by Celltrion' drop 9%
- by Kim, Jin-Gu Jul 29, 2021 05:52am
- (clockwise from the upper left corner) Picture of Actos, Nesina, Edarbi, , Whituben, and Madipin Prescriptions of chronic disease drugs that Celltrion acquired from Takeda Pharmaceuticals dropped 9% year-on-year in the first half of this year. Sales of most of the products were already decreasing in the domestic market at the time of Celltrion’s acquisition, and the prolonged COVID-19 crisis contracted the prescription market and further decreased sales of the products. According to the pharmaceutical market research institution UBIST on the 28th, sales of all the prescription drugs that Celltrion acquired from Takeda Pharmaceutical last year amounted to 33.4 billion won in H1 of this year. This is a 9% drop from the 36.8 billion won earned from prescription drugs in H1 of the previous year. Last June, Celltrion had acquired business rights for Takeda Pharmaceutical’s primary care products in the Asia-Pacific region for 332.4 billion won. Under the deal, Celltrion has the right to 18 products ranging from treatments for diabetes, hypertension, as well as other OTC products in nine Asian Pacific markets including South Korea. Among the 18 brands, ‘Nesina,’ ‘Actos,’ and ‘Basen’ for diabetes, and ‘Edarbi’ and ‘Madipin’ for hypertension, and the OTC drugs ‘Whituben’ and ‘Albothyl’ are currently approved in Korea. Performance of all acquired prescription drugs had fallen in one year. In the case of the Nesina series -Nesina, Nesina Act, and Nesina Met – sales decreased 9% from 16.2 billion won in the H1 last year to 14.7 billion won in H1 this year. Prescription sales of the Actos series -Actos, Actos Met, and Actorsryl – also fell 8% from 12.3 billion won to 11.4 billion won in the same period. Edarbi and Edarbyclor’s prescriptions also decreased 7% from 5.1 billion won to 4.8 billion won, and Mardipin and Basen’s sales also fell 20% (2.1 billion→1.7 billion won) and 16% (1 billion→0.8 billion won), respectively. Most of the products have been in the Korean market for a long time. Mardipin and Basen were approved in 1991 and 1995, and have been in the market for over 30 years. Actos was approved in 2001 and has now been in Korea for 20 years. Nesina was approved in 2013. Their markets have naturally gotten more competitive since then. New products with improved efficacy and safety were released one after another, and generics also entered the market after patent expiry. Due to such various factors, sales of most of the products were already declining or barely maintaining their performance in Korea. Edarbi, which was released in 2017, was also unable to make a significant impact in Korea. In addition, the prolonged COVID-19 crisis had contracted Korea’s outpatient prescription market in general, leading to a larger decline in the performance of these products. Sales performance data on the OTC drugs Whituben and Albothyl for H1 of this year has not been released yet. However, due to the prolonged COVID-19 crisis and the fact that the OTC drug market had contracted more greatly than the prescription drug market, a considerable drop in their sales is expected for H1 this year. Only in the first quarter of this year, sales of the two OTC products had fallen to nearly half of what they made in the first quarter last year (based on IQVIA data). Whituben’s sales fell 51% (1.2 billion won→0.6 billion won), and Albothyl’s sales fell 49% (0.9 billion won → 0.5 billion won).
- Company
- Anterogen to finish analysis for its diabetic foot ulcer Tx
- by Lee, Seok-Jun Jul 29, 2021 05:52am
- Anterogen will be completing data cleaning on its Phase III trial (DFU-301) that was conducted in Korea at the end of August at the earliest. If the analysis goes as planned, the company plans to seek marketing authorization for its product after completing the analysis. 자료: 안트로젠 Anterogen announced these plans at the IR meeting on the 28th. According to IR, Anterogen is currently developing a dressing-type stem cell therapy product for the treatment of diabetic foot ulcers. Two Phase III trials - DFU-301and DFU-302 – had been ongoing for the said product in Korea. Regarding the DFU-301 trial that is now complete, a company official said, “The company aims to complete data cleaning of the Phase III DFU-301 trial in Korea by late August to early September at the latest., and then apply for marketing authorization of the product.” 164 patients participated in the Phase III DFU-301 trial. Grade 1 (106) and Grade 2 (44) patients under the Wagner Diabetic Foot Ulcer Grade Classification System were included in the study. The trial was conducted at 9 institutions. The other Phase III clinical trial, DFU-302, is being conducted on 104 Grade 2 (44) patients under the 'Wager Grade.’ 5 institutions are currently registering participants for the trial. 자료: 안트로젠 Two other Phase II trials on the diabetic foot ulcer treatment are also being conducted in the U.S. Unlike in Korea, the two trials are separately being conducted on 'Wager Grade' Grade 1 and Grade 2 patients. The DFU-102 is being conducted on 56 Grade 1 patients, and the DFU-103 is being conducted on 64 Grade 2 patients. 40 patients are currently registered in the DFU-102 trial.
- Company
- Viatris and Organon's sales are sluggish
- by Kim, Jin-Gu Jul 29, 2021 05:52am
- Viatris, which was officially launched at the end of last year, had low sales in the first half of this year. The amount of outpatient prescriptions for major products decreased by 8% compared to the first half of last year before independence from the Pfizer. Organon, separated from MSD, has a similar situation. Prescription performance of major products decreased by 8% during the same period. Foreign prescription sales were low due to prolonged COVID-19 outbreak. ◆The first half of Lipitor prescription was reduced by 8% According to UBIST, a pharmaceutical market research institute on the 28th, Viatris' total amount of prescriptions for major out-of-the-road prescriptions in the first half of this year is ₩14.4 billion. Compared to ₩217.8 billion in the first half of last year, it decreased by 8%. Viatris was officially launched in November last year. Pfizer Upjohn and Mylan, the Pfizer patent expiration business units, have merged to form a new corporation. Lipitor, Norvasc, Lyrica, Celebrex and Viagra, which were previously sold under the name of Pfizer, have been transferred to Viatris. Most of the major products' outpatient prescriptions have decreased simultaneously. In the case of Lipitor, which is the top item in the domestic outpatient prescription market, it decreased 8% from ₩94.1 billion to ₩86.5 billion during the period. The same is true of other products. Norvasc decreased by 7% (₩33.6 billion → ₩31.1 billion), ·Lyrica 10% (₩32.4 billion → ₩29.3 billion), and Celebrex 4% (₩20.2 billion → ₩19.4 billion). In addition, sales for Caduet ·Neurontin·Xalatan·Cardura XL·Zoloft·Xanax·Efexor-XR SR·Detrusitolalso decreased. Although Xalacom·Zyvox·Lyrica CR increased year-on-year, the prescription amount was only around ₩500 million. The prolonged COVID outbreak has had some impact. The domestic foreign prescription market has entered a slump due to the prolonged COVID crisis. In fact, the domestic foreign prescription market fell 3% year-on-year in the first half of this year. It has fallen in a row since the third quarter of last year. Since COVID outbreak, the number of patients visiting clinics has decreased, and the market has stagnated as pharmaceutical companies' sales and marketing activities have shrunk. Multinational pharmaceutical companies are believed to have reduced prescription performance due to their weaker sales power to lawmakers compared to domestic companies. For example, in the case of Lipitor, prescription sales reached around ₩48 billion every quarter by 2019, but only ₩46 billion from last year when COVID outbreak began in earnest. Sales fell further to ₩43 billion in the first and second quarters of this year. ◆ Atozet ↑2% - Cozaar ↓11% - Singulair ↓18% Organon was officially launched last June. Biosimilar distributed by MSD through Samsung Bioepis has been transferred to Organon in foreign markets such as Atozet, Cozaar, Singular, and Vytorin, products from the Women's Health Business Department, and Renflexis·Brensis·Ontruzant. Among major products, Atozet's prescription performance has increased. It increased 2% from ₩36.4 billion in the first half of last year to ₩37.1 billion. Sales of Cozaar fell 11% from ₩25.3 billion to ₩22.4 billion during the same period. Singulair decreased 18% from ₩14.4 billion to ₩11.8 billion, and Vytorin 17% ( ₩10.4 billion→ ₩8.6 billion), Proscar 9% ( ₩8.6 billion→ ₩7.8 billion), Fosamax 12% ( ₩7.6 billion → ₩6.7 billion), and Nasonex 10% ( ₩3.5 billion→ ₩3.2 billion).
- Company
- Daewoong's COVID drug PO is effective for patients over 50
- by Lee, Seok-Jun Jul 29, 2021 05:52am
- Daewoong's COVID drug PO has cut the time to improve respiratory symptoms of patients aged 50 or older by half compared to placebo. Daewoong announced the results of Topline in clinical 2b of Coviblock (Camostat), which is being developed as a treatment for COVID-19. Clinical trials were conducted in 24 institutions from February to July this year for 342 patients with mild COVID. The main evaluation variable is the "time it took for clinical symptoms to improve. Other key evaluation variables are 'safety' and 'worsened proportions of patients'. Clinical symptoms include fever, cough, difficulty breathing, chills, muscle aches, headaches, and sore throat, and the degree of symptoms (0-3) has improved to "None" or "Weakness (1)" and remained for 24 hours. The analysis confirmed safety in all patients given Camostat. The time it took for clinical symptoms to improve was 7 days for Camostat compared to 8 days for placebo. A Daewoong Pharmaceutical official said, "Because of the characteristics of mild patients, it was difficult to identify the difference in time taken to improve symptoms due to patients with good symptom management, high natural healing rate, and low drug use conformity." "There is also a limitation in clinical symptom determination standards that are subjective to patients." However, significant results were obtained in patients with high drug conformity. During the test period, the company observed patients taking more than 70% of Camostat or placebo. As a result, the improvement time for 175 patients (86 patients in Camostat group and 89 in placebo group) who are representative symptoms of coughing or having difficulty breathing was reduced by about 40% compared to the placebo group (8 days), indicating statistically significant results. The time to improve respiratory symptoms has been reduced by less than half in patients in their 50s and older, who are more likely to spread to severe diseases. According to an analysis of the symptom improvement time of 98 patients (48 Camostat groups and 50 placebo groups) who had at least one cough or difficulty breathing, Camostat improved more than twice as fast as 9 days in placebo groups on the 4th. Daewoong Pharmaceutical is developing a cure for chronic pancreatitis called "Foistar" as a treatment for COVID-19. Daewoong applied for Coviblock in December last year and completed registration in May this year.
- Company
- Nitrosamines test plan must also be submitted
- by Chon, Seung-Hyun Jul 28, 2021 05:56am
- The government is further strengthening pharmaceutical companies' self-inspection of impurities. Plans should be submitted by the end of this month to test for possible Nitrosamine impurities.. The submission of test results is due in May next year. According to the industry on the 27th, the MFDS recently asked pharmaceutical companies to submit a test plan for drugs that are feared to develop Nitrosamine impurities by the 29th. Pharmaceutical companies should submit to the MFDS a list of products that are feared to cause impurities, a plan to proceed with the test inspection, and a scheduled date of submission of test results. If there is a possibility of impurities among the drugs currently being produced and sold, it should be informed in advance when the test inspection will be carried out and the results will be submitted. In November 2019, the MFDS ordered pharmaceutical companies to submit a report on the possibility of Nitrosamine-related impurities of all raw materials and finished medicines, and the data was submitted in a year and six months. Initially, the MFDS requested submission of data by May last year, but postponed it to May this year. Pharmaceutical companies submitted data indicating the possibility of impurity generation for all licensed raw and finished medicines. The data included the results of checking whether the drug's properties or manufacturing environment could produce Nitrosamine impurities such as N-Nitrosodimethylamine (NDMA). It only shows the list of raw materials and finished drugs in possession and the possibility of impurity generation. For example, if Sodium Nitrite or other Nitrite is used, it is classified as a product that is likely to produce Nitrosamine impurities. The MFDS ordered products that are considered to have a possibility of developing Nitrosamine impurities to report the results of the impurity test by May 31, 2022. It did not mention submission of the test inspection plan. An official from the MFDS explained, "The deadline for submitting the test is about 10 months, but the intention is to quickly conduct the test inspection on products that are at risk of impurities." As the risk of impurities has recently been raised in Sartan series of hypertension treatments and Varenicline, it is interpreted as an intention to check with strict standards by pharmaceutical companies. If Nitrosamine impurities are detected in the future in products that pharmaceutical companies have pointed out as unlikely to produce impurities, they may be held responsible. An official from a pharmaceutical company said, "We are once again looking at the possibility of generating impurities for products being produced and sold according to the MFDS' instructions to submit a test inspection plan."
- Company
- Samsung Biologics record-high earnings of ₩166.8 in Q2
- by An, Kyung-Jin Jul 28, 2021 05:55am
- Samsung Biologics Samsung Biologics posted positive records despite the prolonged COVID-19 crisis. The increased utilization rate of the company’s third plant and new product orders drove the company to record the highest-ever sales and operating profit this quarter. On the 27th, Samsung Biologics announced that its operating profit in Q2 this year was 166.8 billion won, which was a 105.6% year-on-year increase. Its sales revenue also rose 34.0% year-on-year to record 412.2 billion won. Both are the largest-ever quarterly records to be made by the company. The company’s cumulative sales revenue in the first half of this year was 673 billion won, a 30.7% increase from the previous year. Its operating profit also increased 67.8% to record 241.1 billion won. The company believes that the sales increase was possible due to increased new product orders in addition to COVID-19 related products, and the increased utilization rate of its third plant. Also, along with the increase in sales, profitability improved as the increased utilization rate of the third plant began to generate profit in full-scale. In May, Samsung Biologics had signed a CMO deal with Moderna to provide fill-finish manufacturing of Moderna’s COVID-19 vaccine and started production. The company plans to finish establishing a manufacturing facility that can produce the active ingredient of the mRNA vaccine in the first half of next year, and expects it will be able to provide an end-to-end service that covers the full process from manufacturing the active ingredient to the finished product. In addition, the company plans to focus on managing effective operation of its manufacturing facilities and winning early orders for its fourth plant. As a response to the surge in demand for biopharmaceutical products, the company has started building its fourth plant with a capacity of 256,000ℓ in August last year. The plant, when completed, will have the world’s largest production capacity for a single plant. The company plans to commence partial operations by the end of next year and start full operations in 2023. An official from Samsung Biologics said, “We are actively taking orders to complete early orders for our fourth plant, even though a considerable amount of time is left until its completion. We plan to contribute to bringing an early end to the COVID-19 pandemic by stably and promptly supplying COVID-19 vaccines and treatments to those in need around the globe.”
